Atherectomy Devices and Methods

ABSTRACT

Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating an abrasive element within the vessel. The abrasive element can be attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly. In particular embodiments, the handle assembly includes a compressed gas driven turbine member that drives rotation of the drive shaft. The turbine member can be rotatably attached to a carriage that is longitudinally translatable in relation to a housing of the handle assembly. The handle assembly can include a latch mechanism that when actuated allows the carriage to translate to a proximal-most position. While the carriage is in the proximal-most position, an open pathway is created so that a guidewire can be slidably passed through the handle assembly and a lumen of the drive shaft.

TECHNICAL FIELD

This document relates to rotational atherectomy devices and systems forremoving or reducing stenotic lesions in blood vessels, for example, byrotating an abrasive element within the vessel to partially orcompletely remove the stenotic lesion material.

BACKGROUND

Atherosclerosis, the clogging of arteries with plaque, is often a causeof coronary heart disease or vascular problems in other regions of thebody. Plaque is made up of fat, cholesterol, calcium, and othersubstances found in the blood. Over time, the plaque hardens and narrowsthe arteries. This limits the flow of oxygen-rich blood to organs andother parts of the body.

Blood flow through the peripheral arteries (e.g., carotid, iliac,femoral, renal etc.), can be similarly affected by the development ofatherosclerotic blockages. Peripheral artery disease (PAD) can beserious because without adequate blood flow, the kidneys, legs, arms,and feet may suffer irreversible damage. Left untreated, the tissue candie or harbor infection.

One method of removing or reducing such blockages in blood vessels isknown as rotational atherectomy. In some implementations, a drive shaftcarrying an abrasive burr or other abrasive surface (e.g., formed fromdiamond grit or diamond particles) rotates at a high speed within thevessel, and the clinician operator slowly advances the atherectomydevice distally so that the abrasive burr scrapes against the occludinglesion and disintegrates it, reducing the occlusion and improving theblood flow through the vessel.

SUMMARY

Some embodiments of rotational atherectomy systems described herein canremove or reduce stenotic lesions in blood vessels by rotating anabrasive element to abrade and breakdown the lesion. In someembodiments, the abrasive element is attached to a distal portion of anelongate flexible drive shaft that extends from a handle assembly. Inparticular embodiments, the handle assembly includes a rotatable turbinemember that drives rotation of the drive shaft (for example, in responseto pressurized gas or other fluid being controllably delivered to act onthe turbine member). In various embodiments, the turbine member isrotatably attached to a carriage that is longitudinally translatable inrelation to a housing of the handle assembly (so that the turbine membertranslates longitudinally with the carriage relative to the housing).Optionally, the handle assembly can include a latch mechanism that canbe actuated to allow the carriage to translate to a first position(e.g., a proximal-most position in some embodiments described below)relative to the housing. The first position of the carriage may be aguidewire advancing/withdrawing position in that, while the carriage isin the first position, a guidewire pathway is opened so that a guidewirecan be slidably passed through the handle assembly and a lumen of thedrive shaft. In some cases, while the carriage is shifted away from thefirst position (e.g., not in the proximal-most position in someembodiments described below) to an operative position, the guidewirepathway is closed by a seal that hinders liquid egress from a proximalend of the drive shaft. In one implementation, a rotational atherectomydevice includes: an elongate flexible drive shaft comprising atorque-transmitting coil (the drive shaft defining a central lumen and alongitudinal axis); an abrasive element attached to a distal portion ofthe drive shaft such that a center of mass of the abrasive element isoffset from the longitudinal axis; a turbine member coupled to aproximal portion of the drive shaft such that rotation of the turbinemember rotates the drive shaft about the longitudinal axis; and anadjustable seal positioned proximally of the turbine member to hinderliquid egress from a proximal end of the central lumen. The adjustableseal has a self-closing portion that is openable to slidably receive aguidewire through the adjustable seal and that is closable to provide aseal of the proximal end of the central lumen.

Such a rotational atherectomy device may optionally include one or moreof the following features. The rotational atherectomy device may alsoinclude a handle assembly in which the turbine member is housed. Therotational atherectomy device may also include a sheath having aproximal end attached to the handle assembly. The sheath may define asheath lumen therethrough in which the drive shaft is slidably disposed.In some embodiments, the sheath includes an inflatable membersurrounding a distal end portion of the sheath. The inflatable membermay define one or more perfusion openings configured to allow fluid flowbetween a proximal end of the inflatable member and a distal end of theinflatable member. The rotational atherectomy device may also include acarriage to which the turbine member is coupled. In some embodiments,the carriage is longitudinally translatable in relation to a housing ofthe handle assembly. Such longitudinal translations of the turbinemember may result in corresponding longitudinal translations of thedrive shaft.

In another implementation, a rotational atherectomy device includes: ahandle assembly; an elongate flexible drive shaft comprising atorque-transmitting coil extending from the handle assembly (the driveshaft defining a central lumen and a longitudinal axis); an abrasiveelement attached to the drive shaft such that a center of mass of theabrasive element is offset from the longitudinal axis; a turbine memberdisposed within the handle assembly and coupled to the drive shaft suchthat rotation of the turbine member drives rotation of the drive shaftabout the longitudinal axis; and a valve coupled to the handle assemblyto control rotation of the turbine member between a rotationally stoppedstate and a rotationally moving state.

Such a rotational atherectomy device may optionally include one or moreof the following features. The rotational atherectomy device may alsoinclude a carriage to which the turbine member is rotatably attached. Insome embodiments, the carriage may be longitudinally translatable inrelation to a housing of the handle assembly. In particular embodiments,the valve may be coupled to the carriage. The valve may be spring biasedto a closed configuration resulting in the turbine member being in therotationally stopped state. In some cases, the valve may be manuallyactuatable to an open configuration resulting in the turbine memberbeing in the rotationally moving state. The rotational atherectomydevice may also include a sheath having a proximal end attached to thehandle assembly. Such a sheath may define a sheath lumen therethrough inwhich the drive shaft is slidably disposed. The sheath may include aninflatable member surrounding a distal end portion of the sheath. Insome embodiments, the inflatable member may define one or more perfusionopenings configured to allow fluid flow between a proximal end of theinflatable member and a distal end of the inflatable member.

In another implementation, a rotational atherectomy device includes: ahandle assembly including a housing; an elongate flexible drive shaftcomprising a torque-transmitting coil extending from the housing (thedrive shaft defining a central lumen and a longitudinal axis); anabrasive element attached to the drive shaft such that a center of massof the abrasive element is offset from the longitudinal axis; a turbinemember disposed within the housing and coupled to the drive shaft suchthat rotation of the turbine member rotates the drive shaft about thelongitudinal axis; a carriage to which the turbine member is rotatablyattached, wherein the carriage is longitudinally translatable inrelation to the housing; and a latch mechanism coupled to the housing.Activation of the latch mechanism allows the carriage to translate to afirst position in which the handle assembly positions the drive shaft toreceive or withdrawn a guidewire.

Such a rotational atherectomy device may optionally include one or moreof the following features. When the carriage is located in the firstposition, an access port defined by the housing may be in fluidcommunication with the central lumen of the drive shaft. When thecarriage is shifted away from the first position, an access port definedby the housing may be disconnected from fluid communication with thecentral lumen of the drive shaft. The first position may be aproximal-most position of the carriage. When the carriage is located inthe proximal-most position and the latch mechanism is deactivated, thecarriage may be detained in the proximal-most position. The rotationalatherectomy device may also include a valve coupled to the carriage andoperable to direct fluid to the turbine member for driving rotation ofthe turbine member and the drive shaft.

In another implementation, a rotational atherectomy system includes arotational atherectomy device and a controller operatively connectedwith the rotational atherectomy device. The rotational atherectomydevice includes: a handle assembly including a housing; an elongateflexible drive shaft comprising a torque-transmitting coil extendingfrom the housing (the drive shaft defining a central lumen and alongitudinal axis); an abrasive element attached to the drive shaft suchthat a center of mass of the abrasive element is offset from thelongitudinal axis; a sheath having a proximal end attached to thehousing, the sheath defining a longitudinal sheath lumen therethrough inwhich the drive shaft is slidably disposed; a turbine member disposedwithin the housing and coupled to the drive shaft such that rotation ofthe turbine member rotates the drive shaft about the longitudinal axis;an optical sensor configured for detecting rotation of the turbinemember; and a carriage to which the turbine member is rotatablyattached, wherein the carriage is longitudinally translatable inrelation to the housing. The controller is configured for supplying apressurized gas for rotating the turbine member. In some embodiments,the controller will not supply the pressurized gas unless the opticalsensor is in electrical communication with the controller.

Such a rotational atherectomy system may optionally include one or moreof the following features. In some embodiments, the controller will notsupply the pressurized gas unless a pressure of a flush fluid suppliedto the sheath lumen is above a threshold limit value.

In another implementation, a method of performing a rotationalatherectomy is provided. The method includes: (i) advancing a driveshaft of a rotation atherectomy device along a guide wire so that aneccentric abrasive element of the drive shaft is directed toward atargeted vessel (the drive shaft comprising torque-transmitting coilextending from a handle assembly and being configured to rotate inresponse to rotation of a turbine member housed within the handleassembly); (ii) withdrawing the guidewire from a proximal end of thecentral lumen of the drive shaft and through an adjustable sealpositioned proximal of the turbine member (the adjustable seal having aself-closing portion that shifts from an open configuration to a closedconfiguration that provides a seal); and (iii) after withdrawing theguidewire from the drive shaft and through the adjustable seal, rotatingthe turbine member coupled to the proximal portion of the drive shaft todrive rotation of the drive shaft about a longitudinal axis of the driveshaft.

In another implementation, another method of performing a rotationalatherectomy is provided. The method includes: advancing a drive shaftassembly of a rotation atherectomy device along a guide wire disposedwithin a vasculature of the patient so that a distal end of the driveshaft assembly is advanced toward the targeted lesion. The drive shaftassembly includes: a sheath comprising an elongate tubular memberdefining a lumen therethrough and an inflatable member disposed about adistal end portion of the tubular member; a torque-transmitting coilslidably disposed within the lumen and extending distally from a handleassembly (the torque-transmitting coil configured to rotate in responseto rotation of a turbine member housed within the handle assembly); andone or more abrasive elements attached to a distal end portion of thetorque-transmitting coil. The method also includes: inflating theinflatable member while the inflatable member is positioned at thetargeted lesion (wherein the inflating results in compression of thetargeted lesion); and rotating the turbine member to drive rotation ofthe torque-transmitting coil such that the one or more abrasive elementscontact the targeted lesion.

Some of the embodiments described herein may provide one or more of thefollowing advantages. First, some embodiments of the rotationalatherectomy system are configured to advance the drive shaft and thehandle assembly over a guidewire, and to drive the rotation of the driveshaft after the guidewire is withdrawn from the drive shaft (and,optionally, from the handle assembly too). Accordingly, in someembodiments the handle assemblies provided herein include features thatallow the drive shaft to be positioned over a guidewire, and that allowthe guidewire to be retracted from the drive shaft prior to rotationaloperations of the drive shaft. In addition, a seal mechanism is providedin particular embodiments that seals the proximal end of the drive shaftlumen after the guidewire has been retracted. Rotational operations ofthe drive shaft without engagement with a guidewire provides operationaladvantages such as, but not limited to, providing greater flexibility ofthe drive shaft, and reducing frictional resistance.

Second, some embodiments of the rotational atherectomy devices andsystems provided herein include a handle assembly with a carriage thatis manually translatable during rotation of the drive shaft, resultingin longitudinal translation of the rotating abrasive element in relationto a target lesion. In particular embodiments, a valve (or otherconnector) is mounted on the carriage and operable to control a supplyof compressed gas (or other power source) to a carriage-mounted turbinemember. The turbine member rotationally drives the drive shaft of theatherectomy device. Hence, in some embodiments the valve for actuatingthe rotational operation of the drive shaft is conveniently located onthe translatable carriage of the handle assembly.

Third, some embodiments of the rotational atherectomy devices andsystems include a controller that interfaces with a handle assembly. Thecontroller can be operable, for example, for supplying compressed gas(or other power source) for the turbine member of the handle assembly,and to adjustably control the rotational speed of the turbine member. Insome embodiments, the controller can include one or more fail-safemechanisms that discontinue/prevent the supply of the compressed gas (orother power source) for the turbine member in particular circumstances.For example, in some embodiments the controller will supply thecompressed gas to the turbine member (or otherwise drive rotation of thedrive shaft) only if a sensor device configured to detect the rotationspeed of the turbine member or drive shaft is in electricalcommunication with the controller. In another example, in variousembodiments the controller will supply the compressed gas to the turbinemember (or otherwise drive rotation of the drive shaft) only if adetected fluid pressure of a sheath flush fluid (to be delivered intothe sheath that carries the drive shaft) is above a threshold limit.Such fail-safe mechanism can, in particular implementations,advantageously maintain safe and effective performance of the rotationalatherectomy system.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an example rotational atherectomy systemin accordance with some embodiments.

FIG. 2 shows an example rotational atherectomy device in use within atarget vessel that includes a lesion. An abrasive element of therotational atherectomy device is being rotated at a first longitudinalposition.

FIG. 3 shows the rotational atherectomy device of FIG. 2 with theabrasive element being rotated at a second longitudinal position that isdistal of the first longitudinal position.

FIG. 4 shows the rotational atherectomy device of FIG. 2 with theabrasive element being rotated at a third longitudinal position that isdistal of the second longitudinal position.

FIG. 5 is a schematic diagram of an example rotational atherectomysystem including a drive shaft with an abrasive element, a handleassembly, and a controller.

FIG. 6 shows the schematic diagram of FIG. 5 with a carriage of thehandle assembly and the abrasive element in distal-most positions.

FIG. 7 shows the schematic diagram of FIG. 5 with the carriage of thehandle assembly and the abrasive element in positions that are proximalof the positions shown in FIG. 6.

FIG. 8 shows the schematic diagram of FIG. 5 with the carriage of thehandle assembly and the abrasive element in proximal-most positions.

FIG. 9 shows an exploded perspective view of an example handle assemblyin accordance with some embodiments.

FIG. 10 shows a longitudinal cross-sectional view of the handle assemblyof FIG. 9.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, in some embodiments a rotational atherectomy system100 for removing or reducing stenotic lesions in blood vessels caninclude an actuator handle assembly 110, an elongate flexible driveshaft assembly 130, and a controller 150. The drive shaft assembly 130extends distally from the handle assembly 110. The controller 150 isconnected to the handle assembly 110 via a cable assembly 160. Thehandle assembly 110 and controller 150 can be operated by a clinician tocontrol the rotational atherectomy procedure.

In the depicted embodiment, the elongate flexible drive shaft assembly130 includes a sheath 132 and a flexible drive shaft 136. A proximal endof the sheath 132 is fixed to the handle assembly 110. The flexibledrive shaft 136 is slidably and rotatably disposed within a lumen of thesheath 132. Hence, as described further below, during a rotationalatherectomy procedure the flexible drive shaft 136 is in motion (e.g.,rotating and translating) while the sheath 132 is generally stationary.

In the depicted embodiment, an inflatable member 134 surrounds a distalend portion of the sheath 132. The inflatable member 134 is selectivelyexpandable between a deflated low-profile configuration and an inflateddeployed configuration. In some embodiments, the inflatable member 134can be selectively inflated or deflated by injecting or extracting aninflation fluid (e.g., saline) into the inflatable member 134.Accordingly, in some embodiments the sheath 132 includes an inflationlumen through which the inflation fluid can pass (to and from theinflatable member 134). The inflatable member 134 can be in the deflatedlow-profile configuration during the navigation of the drive shaftassembly 130 through the patient's vasculature to a target location in avessel. Then, at the target location, the inflatable member 134 can beinflated so that the outer diameter of the inflatable member 134contacts the wall of the vessel. In that arrangement, the inflatablemember 134 advantageously stabilizes the drive shaft assembly 130 in thevessel during the rotational atherectomy procedure.

In some embodiments, the inflatable member 134 or the sheath 132 maydefine one or more passageways that facilitate on-going perfusion in thevessel even while the inflatable member 134 is expanded and in contactwith the wall of the vessel. Such passageways may be around theperimeter of the inflatable member 134, through the inflatable member134 in one or more areas within the periphery defined by the inflatablemember 134, or through the sheath 132.

The flexible driveshaft 136 is slidably and rotatably disposed within alumen of the sheath 132. A distal end portion of the driveshaft 136extends distally of the inflatable member 134 such that the distal endportion of the driveshaft 136 is exposed (i.e., not within the sheath132). The exposed distal end portion of the driveshaft 136 includes oneor more abrasive elements 138, a distal stability element 140, and adistal drive shaft extension portion 142. In the depicted embodiment,the one or more abrasive elements 138 are eccentrically fixed to thedriveshaft 136 between the inflatable member 134 and the distalstability element 140. The distal stability element 140 isconcentrically fixed to the driveshaft 136 between the one or moreabrasive elements 138 and the distal drive shaft extension portion 142.The distal drive shaft extension portion 142 extends distally from thedistal stability element 140 and terminates at a free end.

In the depicted embodiment, the distal stability element 140 has acenter of mass that is axially aligned with a central longitudinal axisof the drive shaft 136 while the one or more abrasive elements 138 havea center of mass that is axially offset from central longitudinal axisof the drive shaft 136. As the drive shaft 136 is rotated about itslongitudinal axis, centrifugal force will cause the one or more abrasiveelements 138 to follow a transverse circular orbit around thelongitudinal axis. The orbiting one or more abrasive elements 138 willcontact the stenotic lesion to ablate the lesion to a reduced size. Thedistal stability element 140 will remain generally at the longitudinalaxis of the drive shaft 136 as the drive shaft 136 is rotated. Asdescribed further below, contemporaneous with the rotation of the driveshaft 136, the drive shaft 136 can be translated along the longitudinalaxis of the drive shaft 136. Hence, lesions can be ablated radially andlongitudinally by virtue of the orbital rotation and translation of theone or more abrasive elements 138, respectively.

The flexible drive shaft 136 of rotational atherectomy system 100 islaterally flexible so that the drive shaft 136 can readily conform tothe non-linear vasculature of the patient, and so that a portion of thedrive shaft 136 adjacent to the one or more abrasive elements 138 willlaterally deflect when acted on by the centrifugal forces resulting fromthe rotation of the one or more abrasive elements 138. In thisembodiment, the drive shaft 136 comprises one or more helically woundwires (or filars). In some embodiments, the one or more helically woundwires are made of a metallic material such as, but not limited to,stainless steel (e.g., 316, 316L, or 316LVM), nitinol, titanium,titanium alloys (e.g., titanium beta 3), carbon steel, or anothersuitable metal or metal alloy. In some alternative embodiments, thefilars are or include graphite, Kevlar, or a polymeric material. In someembodiments, the filars can be woven, rather than wound. In someembodiments, individual filars can comprise multiple strands of materialthat are twisted, woven, or otherwise coupled together to form a filar.In some embodiments, the filars have different cross-sectionalgeometries (size or shape) at different portions along the axial lengthof the drive shaft 136. In some embodiments, the filars have across-sectional geometry other than a circle, e.g., an ovular, square,triangular, or another suitable shape.

In this embodiment, the drive shaft 136 has a hollow core. That is, thedrive shaft 136 defines a longitudinal lumen running therethrough. Thelumen can be used to slidably receive a guidewire therein, as will bedescribed further below. In some embodiments, the lumen can be used toaspirate particulate or to convey fluids that are beneficial for theatherectomy procedure.

In some embodiments, the drive shaft 136 includes a coating on one ormore portions of the outer diameter of the drive shaft 136. The coatingmay also be described as a jacket, a sleeve, a covering, a casing, andthe like. In some embodiments, the coating adds column strength to thedrive shaft 136 to facilitate a greater ability to push the drive shaft136 through stenotic lesions. In addition, the coating can enhance therotational stability of the drive shaft 136 during use. In someembodiments, the coating is a flexible polymer coating that surrounds anouter diameter of at least a portion of drive shaft 136 (e.g., a distalportion of the drive shaft 136 extending from the free end to a locationproximal to the inflatable member 134). In some embodiments, a portionof the drive shaft 136 is uncoated (e.g., from the location proximal tothe inflatable member 134 to the handle 110). In particular embodiments,the coating is a fluid impermeable material such that the lumen of thedrive shaft 136 provides a fluid impermeable flow path along coatedportions of the drive shaft 136.

The coating may be made of materials including, but not limited to,PEBEX, PICOFLEX, PTFE, ePTFE, FEP, PEEK, silicone, PVC, urethane,polyethylene, polypropylene, and the like, and combinations thereof. Inthe some embodiments, the coating covers the distal stability element140 and the distal extension portion 142, thereby leaving only the oneor more abrasive elements 138 exposed (non-coated) along the distalportion of the drive shaft 136. In alternative embodiments, the distalstability element 140 is not covered with the coating, and thus would beexposed like the abrasive element 140. In some embodiments, two or morelayers of the coating can be included on portions of the drive shaft136. Further, in some embodiments different coating materials (e.g.,with different durometers and/or stiffnesses) can be used at differentlocations on the drive shaft 136.

In the depicted embodiment, the distal stability element 140 is acylindrical member having an inner diameter that surrounds a portion ofthe outer diameter of the drive shaft 136. In some embodiments, thedistal stability element 140 has a longitudinal length that is greaterthan a maximum exterior diameter of the distal stability element 140. Inthe depicted embodiment, the distal stability element 140 is coaxialwith the longitudinal axis of the drive shaft 136. Therefore, the centerof mass of the distal stability element 140 is axially aligned(non-eccentric) with the longitudinal axis of the drive shaft 136. Inalternative rotational atherectomy device embodiments, stabilityelement(s) that have centers of mass that are eccentric in relation tothe longitudinal axis may be included in addition to, or as analternative to, the coaxial stability elements 140. For example, in somealternative embodiments, the stability element(s) can have centers ofmass that are eccentric in relation to the longitudinal axis and thatare offset 180 degrees in relation to the center of mass of the one ormore abrasive elements 138.

The distal stability element 140 may be made of a suitable biocompatiblematerial, such as a higher-density biocompatible material. For example,in some embodiments the distal stability element 140 may be made ofmetallic materials such as stainless steel, tungsten, molybdenum,iridium, cobalt, cadmium, and the like, and alloys thereof. The distalstability element 140 has a fixed outer diameter. That is, the distalstability element 140 is not an expandable member in the depictedembodiment. The distal stability element 140 may be mounted to thefilars of the drive shaft 136 using a biocompatible adhesive, bywelding, by press fitting, and the like, and by combinations thereof.The coating may also be used to attach or to supplement the attachmentof the distal stability element 140 to the filars of the drive shaft136. Alternatively, the distal stability element 140 can be integrallyformed as a unitary structure with the filars of the drive shaft 136(e.g., using filars of a different size or density, using filars thatare double-wound to provide multiple filar layers, or the like). Thedistal stability element 140 has an exterior cylindrical surface that issmoother and different from an abrasive exterior surface of the one ormore abrasive elements 138.

Still referring to FIG. 1, the one or more abrasive elements 138, whichmay also be referred to as a burr, can comprise a biocompatible materialthat is coated with an abrasive media such as diamond grit, diamondparticles, silicon carbide, and the like. In the depicted embodiment,the one or more abrasive elements 138 includes a total of five discreteabrasive elements that are spaced apart from each other. In someembodiments, one, two, three, four, six, seven, eight, or more thaneight discrete abrasive elements are included as the one or moreabrasive elements 138. Each of the five discrete abrasive elements caninclude the abrasive media coating. In the depicted embodiment, the twooutermost abrasive elements are smaller in diameter than the three innerabrasive elements.

The center of mass of the one or more abrasive elements 138 is offsetfrom the longitudinal axis of the drive shaft 136. Therefore, as theeccentric one or more abrasive elements 138 are rotated in an orbitalpath, at least a portion of the abrasive surface of the one or moreabrasive elements 138 can make contact with surrounding stenotic lesionmaterial. As with the distal stability element 140, the eccentric one ormore abrasive elements 138 may be mounted to the filars of the driveshaft 136 using a biocompatible adhesive, welding, press fitting, andthe like. Alternatively, the one or more abrasive elements 138 can beintegrally formed as a unitary structure with the filars of the driveshaft 136 (e.g., using filars that are wound in a different pattern tocreate an axially offset structure, or the like).

In some embodiments, the spacing of the distal stability element 140relative to the one or more abrasive elements 138 and the length of thedistal extension portion 142 can be selected to advantageously provide astable and predictable rotary motion profile during high-speed rotationof the drive shaft 136. For example, in embodiments that include thedistal driveshaft extension portion 142, the ratio of the length of thedistal driveshaft extension 142 to the distance between the centers ofthe one or more abrasive elements 138 and the distal stability element140 is about 1:1, about 1.1:1, about 1.2:1, about 1.5:1, about 2:1,about 2.5:1, about 3:1, or higher than 3:1.

Still referring to FIG. 1, the rotational atherectomy system 100 alsoincludes the actuator handle assembly 110. The actuator handle assembly110 includes a housing 112 and a carriage assembly 114. The carriageassembly 114 is slidably translatable along the longitudinal axis of thehandle assembly 110 as indicated by the arrow 115. As the carriageassembly 114 is translated in relation to the housing 112, the driveshaft 136 translates in relation to the sheath 132 in a correspondingmanner.

The carriage assembly 114 includes a valve actuator 116. In the depictedembodiment, the valve actuator 116 is a button that can be depressed toactuate a compressed gas control valve (FIGS. 9 and 10) mounted to thecarriage assembly 114. While the valve actuator 116 is depressed, acompressed gas (e.g., air, nitrogen, etc.) is supplied through the valveto a turbine member (FIG. 10) that is rotatably coupled to the carriageassembly 114 and fixedly coupled to the drive shaft 136. Hence, anactivation of the valve actuator 116 will result in a rotation of theturbine member and, in turn, the drive shaft 136 (as depicted by arrow137). It should be understood that the rotational atherectomy system 100is configured to rotate the drive shaft 136 at a high speed of rotation(e.g., 20,000-160,000 rpm) such that the eccentric one or more abrasiveelements 138 revolve in an orbital path to thereby contact and removeportions of a target lesion (even those portions of the lesion that arespaced farther from the axis of the drive shaft 136 than the maximumradius of the one or more abrasive elements 138).

To operate the handle assembly 110 during a rotational atherectomyprocedure, a clinician can grasp the carriage assembly 114 and depressthe valve actuator 116 with the same hand. The clinician can move(translate) the carriage assembly 114 distally and proximally by hand(in relation to the housing 112), while maintaining the valve actuator116 in the depressed state. In that manner, a target lesion(s) can beablated radially and longitudinally by virtue of the resulting orbitalrotation and translation of the one or more abrasive elements 138,respectively.

In the depicted embodiment, the handle assembly 110 also includes acarriage docking latch actuator 118. As described further below, thecarriage docking latch actuator 118 can be actuated (e.g., depressed) toallow the carriage assembly 114 to translate to a proximal-most positionin which an access port 120 defined by the housing 112 is put into fluidcommunication with the lumen of the drive shaft 136. In thatproximal-most position, a guidewire can be readily installed or removedfrom the lumen of the drive shaft 136 via the access port 120. While thecarriage assembly 114 is in the proximal-most position, the carriagedocking latch actuator 118 can be released and the carriage assembly 114will remain releasably latched in the proximal-most position.Thereafter, actuation of the carriage docking latch actuator 118 willallow the carriage assembly 114 to be translated distally away from theproximal-most position. While the carriage assembly 114 is located inany position other than the proximal-most position, the carriage dockinglatch actuator 118 will not allow the carriage assembly 114 to be movedinto the proximal-most position unless the carriage docking latchactuator 118 is actuated.

Still referring to FIG. 1, the rotational atherectomy system 100 alsoincludes the controller 150. In some embodiments, the controller 150 ispole-mounted. The controller 150 can be used to control particularoperations of the handle assembly 110 and the drive shaft assembly 130.For example, the controller 150 can be used to compute, display, andadjust the rotational speed of the drive shaft 136.

In some embodiments, the controller 150 can include electronic controlsthat are in electrical communication with a turbine RPM sensor locatedon the carriage assembly 114. The controller 150 can convert thesignal(s) from the sensor into a corresponding RPM quantity and displaythe RPM on a user interface 152. If a speed adjustment is desired, theclinician can increase or decrease the rotational speed of the driveshaft 136 using an RPM adjustment device 154 on the controller 150. Inresult, a flow or pressure of compressed gas supplied from thecontroller 150 to the handle assembly 110 (via the cable assembly 160)will be modulated. The modulation of the flow or pressure of thecompressed gas will result in a corresponding modulation of the RPM ofthe turbine member and the drive shaft 136.

In some embodiments, the controller 150 includes one or more interlockfeatures that can enhance the functionality of the rotationalatherectomy system 100. In one such example, if the controller 150 doesnot detect any electrical signal (or a proper signal) from the turbineRPM sensor, the controller 150 can discontinue the supply of compressedgas. In another example, if a pressure of a flush liquid supplied to thesheath 132 is below a threshold pressure value, the controller 150 candiscontinue the supply of compressed gas.

Referring also to FIGS. 2-4, the rotational atherectomy system 100 canbe used to treat a vessel 10 having a stenotic lesion 14 along an innerwall 12 of the vessel 10. The rotational atherectomy system 100 is usedto fully or partially remove the stenotic lesion 14, thereby removing orreducing the blockage within the vessel 10 caused by the stenotic lesion14. By performing such a treatment, the blood flow through the vessel 10may be thereafter increased or otherwise improved. The vessel 10 andlesion 14 are shown in longitudinal cross-sectional views to enablevisualization of the rotational atherectomy system 100.

Briefly, in some implementations the following activities may occur toachieve the deployed arrangement shown in FIGS. 2-4. An introducersheath (not shown) can be percutaneously advanced into the vasculatureof the patient. A guidewire (not shown) can then be inserted through alumen of the introducer sheath and navigated within the patient'svasculature to a target location (e.g., the location of the lesion 14).Techniques such as x-ray fluoroscopy or ultrasonic imaging may be usedto provide visualization of the guidewire and other atherectomy systemcomponents during placement. Next, the rotational atherectomy system 100can be inserted over the guidewire. For example, an opening to the lumenof the drive shaft 136 at the distal free end of the drive shaft 136 canbe placed onto the guidewire, and then the drive shaft assembly 130 andhandle assembly 110 can be gradually advanced over the guidewire to theposition in relation to the lesion 14 as shown. The inflatable member134 is configured in its deflated, low-profiled configuration during theadvancing. In some cases, the drive shaft 136 is disposed fully withinthe lumen of the sheath 132 during the advancing. In some cases, adistal end portion of the drive shaft 136 extends from the distal endopening 143 of the sheath 132 during the advancing. Preferably, thecarriage assembly 114 is latched in its proximal-most docking positionduring the advancement of the drive shaft assembly 130, and handleassembly 110 over the guidewire. Eventually, after enough advancing, theproximal end of the guidewire will extend proximally from the handleassembly 110 (via the access port 120 defined by the handle housing112). Next, the guidewire can be withdrawn from the patient by pullingthe guidewire out from the access port 120 defined by the handle housing112. After withdrawing the guidewire, the carriage docking latchactuator 118 can be activated to allow the carriage assembly 114 to movefrom its proximal-most position. The inflatable member 134 can beinflated so that it contacts the inner wall 12 of the vessel 10. Then,the rotation and translational motions of the drive shaft 136 and one ormore abrasive elements 138 (as depicted by FIGS. 2-4) can be commencedto perform ablation of the lesion 14.

In some implementations, prior to the ablation of the lesion 14 by theone or more abrasive elements 138, the inflatable member 134 can be usedas an angioplasty balloon. That is, sheath 132 can be advanced to aposition that places the inflatable member 134 within the lesion 14. Theinflatable member 134 can then be inflated to compress the lesion 14against the inner wall 12 of the vessel 10. Thereafter, the rotationalatherectomy procedure can be performed. In some implementations, theinflatable member 134 can be used as an angioplasty balloon after therotational atherectomy procedure is performed. In some implementations,additionally or alternatively, a stent can be placed at lesion 14 usingthe inflatable member 134 or another balloon member associated with thedrive shaft assembly 130 after the rotational atherectomy procedure isperformed.

In some implementations, the guidewire is withdrawn completely out ofthe lumen of the drive shaft 136 prior to ablation of the lesion 14 (asdescribed above). In other implementations, the guidewire is withdrawnonly partially. That is, in some implementations a portion of theguidewire remains within the lumen of the drive shaft 136 duringrotation of the drive shaft 136, but remains only in the portion that isnot subject to the significant orbital path in the area of the one ormore abrasive elements 138. After the guidewire is withdraw (fully orpartially), the drive shaft 136 is then rotated at a high rate ofrotation (e.g., 20,000-160,000 rpm) such that the eccentric one or moreabrasive elements 138 revolve in an orbital path about an axis ofrotation and thereby contacts and removes portions of the lesion 14.

Still referring to FIGS. 2-4, the rotational atherectomy system 100 isdepicted during the high-speed rotation of the drive shaft 136. Thecentrifugal force acting on the eccentrically weighted one or moreabrasive elements 138 causes the one or more abrasive elements 138 toorbit in an orbital path around the axis of rotation 139. In someimplementations, the orbital path can be somewhat similar to the motionof a “jump rope.” As shown, some portions of the drive shaft 136 (e.g.,a portion that is just distal of the inflatable member 134 and anotherportion that is distal of the distal stability element 140) can remainin general alignment with the axis of rotation 139, but the particularportion of the drive shaft 136 adjacent to the one or more abrasiveelements 138 is not aligned with the axis of rotation 139 (and insteadorbits around the axis 139).

In some implementations, as the one or more abrasive elements 138rotates, the clinician operator slowly advances the carriage assembly114 distally (and, optionally, reciprocates both distally andproximally) along the longitudinal axis of the drive shaft 136 and thehandle assembly 110 so that the abrasive surface of the one or moreabrasive elements 138 scrapes against additional portions of theoccluding lesion 14 to reduce the size of the occlusion, and to therebyimprove the blood flow through the vessel 10. This combination ofrotational and translational motion of the one or more abrasive elements138 is depicted by the sequence of FIGS. 2-4.

In some embodiments, the inflatable member 134 or the sheath 132 maydefine one or more passageways 141 that facilitate on-going perfusion inthe vessel even while the inflatable member 134 is expanded and incontact with the wall of the vessel. Such passageways 141 may be aroundthe perimeter of the inflatable member 134 (between the inflatablemember 134 and the inner wall 12 of the vessel 10), through theinflatable member 134 in one or more areas within the periphery definedby the inflatable member 134, or through the sheath 132 (as depicted).In the depicted arrangement, blood in the vessel 10 can continue to flowby passing through the sheath 132 between the one or more passageways141 and the distal end opening 143 of the sheath 132.

Referring to FIG. 5, the rotational atherectomy system 100 can bedepicted schematically to allow for further description of the system100. Here, the sheath 132 is shown in partial longitudinal cross-sectionto allow for visualization of the features therein, and the boundary ofthe handle assembly 110 is shown in dashed lines. As described above,the rotational atherectomy system 100 includes the handle assembly 110,the drive shaft assembly 130, and the controller 150.

The drive shaft assembly 130 includes the sheath 132 (with theinflatable member 136) and the drive shaft 136. The drive shaft 136 isslidably and rotatably disposed within a longitudinal lumen defined bythe sheath 132. A clearance exists between the drive shaft 136 and theinner diameter of the longitudinal lumen defined by the sheath 132. Aflush fluid can be supplied via a flush fluid port 133 into theclearance between the drive shaft 136 and the inner diameter of thelongitudinal lumen defined by the sheath 132. The flush fluid canprovide lubrication and cooling between the drive shaft 136 and theinner diameter of the longitudinal lumen defined by the sheath 132.Additionally, the flush fluid can inhibit blood ingress into the driveshaft assembly 130. In some embodiments, the flush fluid port 133 can beused for aspiration.

The drive shaft assembly 130 also includes an inflation fluid port 131.The inflation fluid port 131 is in fluid communication with a lumendefined within the wall of the sheath 132 and with the inflatable member134. Hence, by supplying a fluid via the inflation fluid port 131 (e.g.,using a syringe, pump, etc.) the inflatable member 134 can be inflatedto its expanded configuration. Conversely, by withdrawing a fluid viathe inflation fluid port 131, the inflatable member 134 can be deflatedto its collapsed, low-profile configuration.

The proximal end of the sheath 132 is fixed to the housing 112 of thehandle assembly 110. In some embodiments, pig tails are coupled to theinflation fluid port 131 and or the flush fluid port 133.

The handle assembly 110 includes the turbine member 119. The turbinemember 119 can be driven by compressed gas supplied through a valve 126and a nozzle 128. The turbine member 119, valve 126, and nozzle 128 aremounted to the carriage assembly 114 (FIG. 1). The turbine member 119rotates on bearings 117.

In the depicted configuration, the valve 126 is closed. Therefore, theturbine member 119 and the drive shaft 136 are not rotating in thedepicted configuration.

The handle assembly 110 also includes an RPM sensor 120. In someembodiments, the RPM sensor 120 is an optical sensor that detects thepassage of each vane of the turbine member 119 as the turbine member 119is rotating.

In the depicted embodiment, a proximal end portion of the drive shaft136 is coupled with the turbine member 119 using an intermediary tubularmember 113. The tubular member 113 can be a stainless steel tube, forexample. In some embodiments, the proximal end portion of the driveshaft 136 is bonded within a lumen of the intermediary tubular member113 using an adhesive (e.g., a cyanoacrylate type of adhesive, and thelike). A seal 135 exists between the outer diameter of the intermediarytubular member 113 and the inner diameter of the proximal end of thesheath 132. The seal 135 inhibits the egress of the flush fluid suppliedvia the flush fluid port 133.

The arrangement of the proximal end portion of the drive shaft 136, theintermediary tubular member 113, and the turbine member 119 is such thatan opening to the lumen of the drive shaft 136 is located proximal ofthe turbine member 119. An adjustable seal 121 is positioned at thelocation of the opening. The adjustable seal 121 includes a self-closingportion. While the self-closing portion is closed, the adjustable seal121 hinders liquid egress from the proximal end of the lumen defined bythe drive shaft 136 (and the lumens defined by the intermediary tubularmember 113 and the turbine member 119). While the self-closing portionis opened, a guidewire can be slidably received through the adjustableseal 121, and into the lumens defined by the proximal end portion of thedrive shaft 136, the intermediary tubular member 113, and the turbinemember 119. The operations of the adjustable seal will be describedfurther below (in reference to FIG. 8).

Referring to FIG. 6, the valve 126 can be opened by actuation of thevalve actuator 116, resulting in flow of compressed gas from thecontroller 150, through the valve 126 and the nozzle 128, and rotationof the turbine member 119. The rotation of the turbine member 119, inturn, results in a rotation of the drive shaft 136 as depicted by arrow137. The clinician operator can view the measured RPM of theturbine/drive shaft via the user interface 152, and adjust the speed ofthe rotation via the RPM adjustment device 154 on the controller 150.

Additionally, the clinician operator can translate the carriage assembly114 (FIG. 1) and the drive shaft 136 as depicted by arrow 115. In thedepicted arrangement, the carriage assembly 114 has been translated to adistal-most position.

Referring also to FIG. 7, the clinician operator can also translate thecarriage assembly 114 (FIG. 1) and the drive shaft 136 (as depicted byarrow 115) to a proximal position. In some cases, the clinician operatormay oscillate the carriage assembly 114 between the distal position ofFIG. 6 and the proximal position of FIG. 7 (or to one or moreintermediate positions therebetween) multiple times while the driveshaft 136 is rotating so as to ablate a lesion.

Referring to FIG. 8, the carriage assembly 114 (FIG. 1) can also betranslated to a proximal-most position as illustrated. While thecarriage assembly 114 is located in the proximal-most position (inrelation to the housing 112 of the handle assembly 110), a guidewire canbe readily withdrawn from (or inserted into) the rotational atherectomysystem 100.

To facilitate positioning of the carriage assembly 114 in theproximal-most position, the clinician operator first actuates thecarriage docking latch actuator 118. Then, while the carriage dockinglatch actuator 118 is actuated, the carriage assembly 114 can betranslated to the proximal-most position. In some embodiments, unlessthe carriage docking latch actuator 118 is actuated the carriageassembly 114 is mechanically prevented from translating to theproximal-most position. In some embodiments, while the carriage assembly114 is in the proximal-most position, the carriage assembly 114 isreleasably latched in the proximal-most position. A second actuation ofthe carriage docking latch actuator 118 can unlatch the carriageassembly 114 so that it can be translated distally away from theproximal-most position.

In the depicted embodiment, the act of positioning of the carriageassembly 114 in the proximal-most position results in forcing a sealpuncture member 124 distally into engagement with the adjustable seal121. Said another way, the seal puncture member 124 penetrates theself-closing portion of the adjustable seal 121 when the carriageassembly 114 is translated to the proximal-most position. A lumendefined by the seal puncture member 124 becomes aligned with (and influid communication with) the lumen defined by the drive shaft 136.Therefore, in that arrangement a passageway is created from the accessport 120 defined in the proximal end of the housing 112 to the lumen ofthe drive shaft 136.

While the carriage assembly 114 is located in the proximal-mostposition, a guidewire can be readily withdrawn from (or inserted into)the rotational atherectomy system 100. For example, when installing therotational atherectomy system 100 over a guidewire, the proximal end ofthe guidewire can first be threaded into the open distal tip of thedrive shaft 136. Then the drive shaft assembly 130 (and handle assembly110) can be pushed distally over the guidewire. Eventually, as the driveshaft assembly 130 (and handle assembly 110) continue to be pusheddistally over the guidewire, the proximal end of the guidewire willemerge from the access port 120 defined in the proximal end of thehousing 112. That is the case because, while the carriage assembly 114is located in the proximal-most position, a passageway is opened all theway from the distal tip of the drive shaft 136 to the access port 120defined in the proximal end of the housing 112. To remove the guidewirefrom engagement with the rotational atherectomy system 100, while thecarriage assembly 114 is located in the proximal-most position theguidewire can be pulled proximally out from the access port 120 definedin the proximal end of the housing 112. After withdrawing the guidewirefrom the drive shaft 136 (through the adjustable seal 121), therotational atherectomy system 100 can be operated by supplyingcompressed gas to the turbine member 119 to drive the rotation of thedrive shaft 136.

Referring to FIGS. 9 and 10, the handle assembly 110 is illustrated inexploded and longitudinal cross-sectional views for additionalvisibility of the components of the handle assembly 110. The componentsand functionality of the handle assembly 110 have been described abovein reference to FIGS. 1-8.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention. Forexample, design features of the embodiments described herein can becombined with other design features of other embodiments describedherein. Accordingly, other embodiments are within the scope of thefollowing claims.

What is claimed is:
 1. A rotational atherectomy device comprising: anelongate flexible drive shaft comprising a torque-transmitting coil, thedrive shaft defining a central lumen and a longitudinal axis; anabrasive element attached to a distal portion of the drive shaft suchthat a center of mass of the abrasive element is offset from thelongitudinal axis; a turbine member coupled to a proximal portion of thedrive shaft such that rotation of the turbine member rotates the driveshaft about the longitudinal axis; and an adjustable seal positionedproximally of the turbine member to hinder liquid egress from a proximalend of the central lumen, the adjustable seal having a self-closingportion that is openable to slidably receive a guidewire through theadjustable seal and that is closable to provide a seal of the proximalend of the central lumen.
 2. The rotational atherectomy device of claim1, further comprising a handle assembly in which the turbine member ishoused.
 3. The rotational atherectomy device of claim 2, furthercomprising a sheath having a proximal end attached to the handleassembly, the sheath defining a sheath lumen therethrough in which thedrive shaft is slidably disposed.
 4. The rotational atherectomy deviceof claim 3, wherein the sheath includes an inflatable member surroundinga distal end portion of the sheath.
 5. The rotational atherectomy deviceof claim 4, wherein the inflatable member defines one or more perfusionopenings configured to allow fluid flow between a proximal end of theinflatable member and a distal end of the inflatable member.
 6. Therotational atherectomy device of claim 2, further comprising a carriageto which the turbine member is coupled, wherein the carriage islongitudinally translatable in relation to a housing of the handleassembly, and wherein longitudinal translations of the turbine memberresult in corresponding longitudinal translations of the drive shaft. 7.A rotational atherectomy device comprising: a handle assembly; anelongate flexible drive shaft comprising a torque-transmitting coilextending from the handle assembly, the drive shaft defining a centrallumen and a longitudinal axis; an abrasive element attached to the driveshaft such that a center of mass of the abrasive element is offset fromthe longitudinal axis; a turbine member disposed within the handleassembly and coupled to the drive shaft such that rotation of theturbine member drives rotation of the drive shaft about the longitudinalaxis; and a valve coupled to the handle assembly to control rotation ofthe turbine member between a rotationally stopped state and arotationally moving state.
 8. The rotational atherectomy device of claim7, further comprising a carriage to which the turbine member isrotatably attached, wherein the carriage is longitudinally translatablein relation to a housing of the handle assembly, wherein the valve iscoupled to the carriage.
 9. The rotational atherectomy device of claim8, wherein the valve is spring biased to a closed configurationresulting in the turbine member being in the rotationally stopped state.10. The rotational atherectomy device of claim 8, wherein the valve ismanually actuatable to an open configuration resulting in the turbinemember being in the rotationally moving state.
 11. The rotationalatherectomy device of claim 7, further comprising a sheath having aproximal end attached to the handle assembly, the sheath defining asheath lumen therethrough in which the drive shaft is slidably disposed.12. The rotational atherectomy device of claim 11, wherein the sheathincludes an inflatable member surrounding a distal end portion of thesheath.
 13. The rotational atherectomy device of claim 12, wherein theinflatable member defines one or more perfusion openings configured toallow fluid flow between a proximal end of the inflatable member and adistal end of the inflatable member.
 14. A rotational atherectomy devicecomprising: a handle assembly including a housing; an elongate flexibledrive shaft comprising a torque-transmitting coil extending from thehousing, the drive shaft defining a central lumen and a longitudinalaxis; an abrasive element attached to the drive shaft such that a centerof mass of the abrasive element is offset from the longitudinal axis; aturbine member disposed within the housing and coupled to the driveshaft such that rotation of the turbine member rotates the drive shaftabout the longitudinal axis; a carriage to which the turbine member isrotatably attached, wherein the carriage is longitudinally translatablein relation to the housing; and a latch mechanism coupled to thehousing, wherein activation of the latch mechanism allows the carriageto translate to a first position in which the handle assembly positionsthe drive shaft to receive or withdrawn a guidewire.
 15. The rotationalatherectomy device of claim 14, wherein when the carriage is located inthe first position, an access port defined by the housing is in fluidcommunication with the central lumen of the drive shaft.
 16. Therotational atherectomy device of claim 15, wherein when the carriage isshifted away from the first position, an access port defined by thehousing is disconnected from fluid communication with the central lumenof the drive shaft.
 17. The rotational atherectomy device of claim 14,wherein the first position is a proximal-most position of the carriage,and when the carriage is located in the proximal-most position and thelatch mechanism is deactivated, the carriage is detained in theproximal-most position.
 18. The rotational atherectomy device of claim14, further comprising a valve coupled to the carriage and operable todirect fluid to the turbine member for driving rotation of the turbinemember and the drive shaft.
 19. A rotational atherectomy systemcomprising: a rotational atherectomy device comprising: a handleassembly including a housing; an elongate flexible drive shaftcomprising a torque-transmitting coil extending from the housing, thedrive shaft defining a central lumen and a longitudinal axis; anabrasive element attached to the drive shaft such that a center of massof the abrasive element is offset from the longitudinal axis; a sheathhaving a proximal end attached to the housing, the sheath defining alongitudinal sheath lumen therethrough in which the drive shaft isslidably disposed; a turbine member disposed within the housing andcoupled to the drive shaft such that rotation of the turbine memberrotates the drive shaft about the longitudinal axis; an optical sensorconfigured for detecting rotation of the turbine member; and a carriageto which the turbine member is rotatably attached, wherein the carriageis longitudinally translatable in relation to the housing; and acontroller operatively connected with the rotational atherectomy deviceand configured for supplying a pressurized gas for rotating the turbinemember, wherein the controller will not supply the pressurized gasunless the optical sensor is in electrical communication with thecontroller.
 20. The rotational atherectomy system of claim 19, whereinthe controller will not supply the pressurized gas unless a pressure ofa flush fluid supplied to the sheath lumen is above a threshold limitvalue.
 21. A method of performing a rotational atherectomy, the methodcomprising: advancing a drive shaft of a rotation atherectomy devicealong a guide wire so that an eccentric abrasive element of the driveshaft is directed toward a targeted vessel, the drive shaft comprisingtorque-transmitting coil extending from a handle assembly and beingconfigured to rotate in response to rotation of a turbine member housedwithin the handle assembly; withdrawing the guidewire from a proximalend of the central lumen of the drive shaft and through an adjustableseal positioned proximal of the turbine member, the adjustable sealhaving a self-closing portion that shifts from an open configuration toa closed configuration that provides a seal; and after withdrawing theguidewire from the drive shaft and through the adjustable seal, rotatingthe turbine member coupled to the proximal portion of the drive shaft todrive rotation of the drive shaft about a longitudinal axis of the driveshaft.
 22. A method of performing a rotational atherectomy on a targetedlesion of a patient, the method comprising: advancing a drive shaftassembly of a rotation atherectomy device along a guide wire disposedwithin a vasculature of the patient so that a distal end of the driveshaft assembly is advanced toward the targeted lesion, the drive shaftassembly comprising: a sheath comprising an elongate tubular memberdefining a lumen therethrough and an inflatable member disposed about adistal end portion of the tubular member; a torque-transmitting coilslidably disposed within the lumen and extending distally from a handleassembly, the torque-transmitting coil configured to rotate in responseto rotation of a turbine member housed within the handle assembly; andone or more abrasive elements attached to a distal end portion of thetorque-transmitting coil; inflating the inflatable member while theinflatable member is positioned at the targeted lesion, wherein theinflating results in compression of the targeted lesion; and rotatingthe turbine member to drive rotation of the torque-transmitting coilsuch that the one or more abrasive elements contact the targeted lesion.